HCV Cases Down, But Not Out

The Centers for Disease Control and Prevention (CDC) recently released data analysis from 2022 indicating a 6% decrease in new viral Hepatitis C (HCV) infections, a revelation that leaves infectious disease specialists cautiously optimistic. Yet, despite the existence of a cure, thousands of Americans still die needlessly from this disease each year. Systemic barriers – restrictive insurance policies, inefficient testing, and neglect of marginalized communities – prevent many from accessing the lifesaving treatment they need. These failures fuel a public health crisis, with over 14,000 Americans dying from HCV complications in 2020 alone. The most vulnerable suffer the worst consequences, including young people, people impacted by substance use and the justice system, and those experiencing homelessness. While experts remain cautious, this decline after a decade of steady increases could signal a turning point. "We've had a decade of bad news…I am cautiously encouraged," said Daniel Raymond, director of policy at the National Viral Hepatitis Roundtable. "This could be a sign the tide has turned."

Systemic Barriers to HCV Care

Despite the existence of a cure, a shockingly low percentage of those with HCV achieve viral clearance. Systemic barriers rooted in insurance practices, fragmented testing, and neglect of marginalized communities prevent countless Americans from accessing the treatment they need.

Insurance Roadblocks

Insurance restrictions present a formidable obstacle to HCV treatment, often creating a maze of administrative hurdles. State Medicaid programs frequently require proof of months-long sobriety, specialist-only prescriptions for treatment, or evidence of existing liver damage before approving care. These arbitrary restrictions fly in the face of medical best practices and delay treatment, increasing the risk of liver failure, liver cancer, and even death.

Even those with commercial insurance face barriers to HCV care. Despite the high cost of HCV medications, many insurers impose prior authorization requirements. These delays, coupled with restrictive formularies and high copays, discourage patients and providers. The fact that only about 50% of commercially insured patients in a recent CDC study achieved viral clearance speaks volumes about how deep-seated this issue is, impacting people regardless of their insurance status.

The Burden of Diagnosis

A shocking number of people live with Hepatitis C without knowing it, with the CDC estimating over 40% of those infected are unaware of their status. This highlights a problem of insufficient screening and inefficient testing procedures. The current multi-step diagnostic process, requiring separate blood draws for the initial HCV antibody check and subsequent confirmation, creates logistical barriers. Many face issues like needing multiple appointments, additional travel costs, or potential delays in results.

Populations most impacted by HCV, including young people, those experiencing homelessness or substance use, and people who are incarcerated, often face additional challenges accessing even basic healthcare. Routine HCV screening within prisons, expanded outreach testing in underserved communities, and integration of HCV screening into substance use treatment programs are essential to reaching those at heightened risk.

Modern medicine offers rapid point-of-care tests for many conditions, including HIV. Similar technology exists for HCV, yet approval and widespread use lag behind. Streamlining the diagnostic process through rapid, single-visit testing would revolutionize care by connecting people to treatment far earlier, minimizing disease progression and preventing transmission.

How Barriers Foster Disparities

HCV treatment disparities highlight a system that consistently fails our most vulnerable populations. Cure rates are lowest among those without insurance and people on Medicaid, a stark reflection of restrictive insurance practices and a lack of support to navigate complex healthcare systems. The disease disproportionately impacts marginalized communities, including:

• Young People: Driven by the opioid crisis, new HCV cases have surged among millennials and Gen Z, with over 60% of new chronic infections found in these younger populations. This highlights the need for increased prevention and treatment efforts tailored to this age group.

• People Experiencing Homelessness: Lack of stable housing leads to missed appointments, medication storage issues, and prioritization of immediate survival over long-term health concerns.

• Incarcerated People: An estimated 13% of those moving through prisons and jails annually have HCV, yet treatment is rarely offered. Post-release, they face navigating insurance and accessing care with limited support.

• Those with Substance Use Disorders: Stigma and outdated treatment requirements often bar this population from receiving HCV care. Integrated treatment models, combining HCV care with substance use treatment and harm reduction services, are vital to reaching this underserved population.

Untreated HCV is a Public Health Threat

The systemic barriers discussed – restrictive insurance practices, the cumbersome diagnostic process, and inadequate outreach to marginalized communities – contribute to a critical public health issue: a significant portion of people living with HCV remain undiagnosed and untreated. This compromises their health and increases the risk of unknowingly transmitting the virus through unprotected sex or sharing drug paraphernalia. Ensuring equitable access to HCV testing, treatment, and care is essential to protecting public health. By dismantling these barriers and ensuring everyone has the opportunity to be diagnosed and cured, we can protect those most vulnerable and achieve a future free from HCV.

Cost of Inaction

The human and economic toll of failing to address HCV is staggering:

• Deaths: More than 14,800 Americans died from HCV-related complications in 2020.

• Liver Cancer: HCV is a leading cause of liver cancer, with rates of new cases rising 38% between 2003 and 2012.

• Economic Burden: The Biden Administration's proposed HCV elimination plan projects that over 10 years, it would prevent 24,000 deaths and save $18.1 billion in healthcare costs.

National Strategy & the Biden Plan

The persistent low cure rates, widening health disparities, and the staggering human and economic cost of untreated HCV reveal that relying on any single solution won't achieve elimination. A coordinated national strategy is essential to overcome existing systemic failures and ensure that no one falls through the cracks. The Biden Administration's proposed HCV elimination plan offers a transformative framework for addressing these challenges, but its success hinges on learning from the lessons of past initiatives.

Key Elements of the Biden Plan:

• The "Netflix Model": To address insurance barriers, this model proposes a subscription approach, where the government negotiates a fixed price with drug companies to provide treatment for vulnerable groups (uninsured, Medicaid, incarcerated, and others). This simplifies coverage and ensures those who need it most can access life-saving medication.

• Rapid Testing & Community Focus: Investment in rapid point-of-care testing would enable same-day diagnosis and treatment initiation, revolutionizing care. Federal funding to support expanded testing in non-traditional settings, like mobile clinics, prisons, and substance use treatment centers, would directly reach the populations most impacted by HCV.

• Federal Support & Coordination: Centralized guidance, resources, and funding for healthcare providers are crucial for expanding screening, streamlining care models, and educating both providers and communities.. This investment in public health infrastructure would create a ripple effect, increasing capacity for effective HCV treatment long-term.

Subscription models like those piloted in Louisiana and Washington have demonstrated the potential to reduce medication costs. However, as Jen Laws, CEO of CANN, highlights, even with affordable drugs, systemic shortcomings remain a significant barrier to care. The Biden Plan must recognize that:

• Price isn't the only issue: Drug costs are a major factor but investment in community-based healthcare infrastructure, provider training, outreach programs, and addressing logistical barriers to care and testing are just as crucial.

• Reinvestment of savings is key: The substantial cost-savings generated from the "Netflix model" must be reinvested directly into strengthening public health systems, ensuring long-term success.

• Policy-driven solutions are essential: Federal legislation mandating opt-out HCV screening in hospitals, universal screening in prisons, and cost-sharing limits on commercial insurance plans would provide a powerful foundation to support and guide the Biden Plan.

Addressing Disparities

The Biden Plan's focus on equity directly confronts the health disparities highlighted earlier. By specifically targeting uninsured and Medicaid populations, it helps ensure that financial barriers don't translate into needless deaths. The emphasis on community-based testing and integrated treatment models is crucial for reaching marginalized populations like:

• Young People: Increased outreach and testing aligned with this age group is vital to curbing the surge of new infections fueled by the opioid epidemic.

• People Experiencing Homelessness: Integrating HCV screening and care into supportive services for this population is essential to address their often complex healthcare needs.

• Incarcerated People: By treating HCV within prisons, not only would patient health outcomes improve, but it could also help prevent transmission within facilities and in communities upon release.

• Those with Substance Use Disorders: The plan's support for harm reduction strategies and integrated treatment models recognizes the need to address HCV without discriminatory sobriety restrictions.

The Cost-Benefit Argument

The Biden Plan isn't just compassionate; it's a sound fiscal investment. Projections indicate it would save 24,000 lives and $18.1 billion in healthcare costs over ten year. By preventing long-term HCV complications like liver failure, cancer, and transplants, we can reduce the significant future economic burden of this preventable disease.

Despite a small, yet significant decrease in new HCV infections, there remains the staggering toll of untreated HCV. The promise of the Biden Plan demands immediate action, according to advocates, because it addresses preventable deaths, widening health disparities, and the economic strain of a solvable public health crisis. It will take a larger, systemic approach to remove many of the barriers impending the elimination of Hepatitis C in the United States.

New CDC Report; More than a Decade After a Cure, HepC Persists

Last year, the Centers for Disease Control and Prevention (CDC) published a Vital Signs report detailing how “too few people” are  being “treated for Hepatitis C” (subtitled: “Reducing Barriers Can Increase Treatment and Save Lives”). Today, the CDC’s landing page reflects a finding from April 2020 that reads “dramatic increases in Hepatitis C” (subtitled: “CDC now recommends hepatitis C testing for all adults”). And in late June, the CDC published a new Morbidity and Mortality Weekly Report (MMWR) on a worryingly low rate of HCV clearance in the United States.

Our previous blog reviewed last year’s report under the lens of health disparities highlighted by researchers’ review of 48,000 patient charts that met the inclusion criteria for the analysis. Then, much like in this new report, identified that lack of curative treatment access was not uniform and was largely informed by the type of insurance patients qualified for. Those payer types (Medicaid, Medicare, and Commercial plans) also represent patients from different backgrounds – meaning different socio-economic statuses, different genders and racial backgrounds – with different outcomes. Overall, Medicaid recipients were only ever prescribed curative treatment about 23% of the time, whereas Commercial payer patients were able to see that rate increase to 35%. The CDC also recognized these payers, and the politicians who set the public policy of Medicaid, represent incredibly tangible barriers via administrative processes, like prior authorization, and policy barriers, like requiring sobriety, a high level of liver damage, or other restrictions to gaining access to curative treatments.

For this year’s report, researchers partnered with Quest Diagnostics to review the viral clearance (or cure) of approximately 1 million patients with an initial infection (Quest provided data for 1.7 million patients with evidence of a history of HCV during the direct acting agents era, or from January 1, 2013 – December 31, 2022). Based on an estimated 2.4 million people in the United States with HCV, this sample represents about 43% of those believed to have experienced an HCV infection in this time frame. This is noted as a limitation in the data, in part, because it only represents data from one commercial laboratory. Though, reasonable observers can make certain conclusions from this data.

Now, we should also note, only about 88% of the 1.7 million patients identified as having evidence of HCV infection ever had received testing and, of those, 69% were identified as having an initial infection. This means the majority of patients identified were newly diagnosed and not facing a chronic HCV infection. Of those, about 7% of patients showed evidence of viral persistence.

Authors note “These findings reveal substantial missed opportunities to diagnose, treat, and prevent Hepatitis C in the United States.”

Coverage was highest among those enrolled in commercial insurance (50%) and lowest in Medicare and Medicaid (8% and 9%, respectively). Particularly startling in the differences between payer types was the prevalence of viral testing; those with an unspecified payor type were screened at about 79% and those with commercial insurance or Medicare had a testing prevalence of about 91%.

Patients with “other”, “unspecified”, or Medicaid as their insurance or payer had showed a lower viral clearance rate (23%, 33% and 31% respectively) than their counterparts enrolled in Medicare or commercial plans (40% and 45%, respectively). Overall, the cure rate was about 34%.

The age range with the highest rate of HCV diagnoses was 40-59 years, representing about 43% of the patient records reviewed. 60% were identified in their charts as male. However, the highest rate of viral clearance was among those aged over 60 and the lowest was for those aged between 20-29 years.

Other limitations to the data include a lack of uniformity in the follow-up period between testing, which might lead to some difference in rates. Similarly, patients might use or be referred to a different lab for follow-ups. Though, the data also does not follow patients and would not capture any representation of subsequent reinfection and cannot make any assumptions as to clearance or viral persistence among those who did not have RNA testing (and referral for treatment) – meaning the data likely underestimates the patients in each of these categories.

Advocates can look toward these data and findings to inform necessary policy changes, particularly by payer type and in seeking appropriate provider activation on screening and treatment. The sheer reality is HCV is both preventable and curable and policymakers and payers need to work more efficiently in order to prevent the approximate 14,000 HCV related deaths this country faces annually.

Analysis: Biden’s Budget Request Emphasizes HIV, HCV Goals

On March 9th, President Joe Biden released his proposed budget. As with all Presidents, in all years, and in all sorts of political climates, it outlines what can generously be called a “wish list”. Rarely, even under unified control of the government, does a President’s budget request get a full match. Most often, the budget Congress passes and the budget a President proposes are dramatically different. In 2022 (and in decades past), Biden attributed a quote to his father: “Don’t tell me what you value. Show me your budget – and I’ll show you what you value.” To that end, Biden’s budget proposal has a few notable areas of interest with regard to HIV, hepatitis C, public health in general, and with regard to priorities that might affect various stakeholders along the chain from manufacturing medications to patients.

In a call to advocates, just prior to the full court press release of the President’s budget, White House staff touted a proposed expansion of the Inflation Reduction Act’s (IRA) drug price negotiation provisions to include more medications up for government control of list prices as part of a “savings” counterbalance to expenditures in the proposed budget. It’s important to note no specific medications have yet been proposed under the IRA, any proposed “savings” the government expects to see have not been tested, and, yet again, these potential “savings” are not required to be passed down to patients or even back to the government as a public sponsor of affected plans. Similarly, on the call, officials said the proposed budget would stop “subsidizing” pharmaceutical manufacturers and, immediately thereafter, stated a priority in the budget would be to incentivize innovation as part of the administration’s “Cancer Moonshot”.

There are several HIV-related provisions in the budget request as well. First up, the proposal seeks to expand funding for the Ending the HIV Epidemic initiative started under the previous administration by about $313 million. These dollars would be bolstered by a $90 million increase for HIV prevention activities at the Centers for Disease Control and Prevention (CDC) and a $15 million increase for associated CDC programming around pre-exposure prophylaxis (PrEP) for the prevention of HIV. Notably, these same funds are a portion of dollars Tennessee will be rejecting later this year. Right along with these increases, Biden’s budget seeks to increase Ryan White HIV/AIDS Program funding by $125 million in order to better ensure those already living with HIV have better access to care and treatment.

One of the crowning jewels of the request includes funding for a national PrEP program to the tune of $9.7 billion over 10 years. That particular request may get passed and have some funding, but it is not likely to be funded at this level…or anywhere near sufficiently to meet the need. As it stands, relatively few people who would benefit from PrEP are taking the medication and that number, based on preliminary data for 2022, might be falling again. Largely, PrEP is being used by white men who have sex with men, who are already highly activated, while fewer Black Women and Black men who have sex with men are accessing the medication. A national program may help on this front, but only if it’s handled correctly and carefully. To that end, the CDC has been making a concerted effort to urge primary care providers to adjust their comfort level with prescribing PrEP and having conversations with patients about their sexual activities.

The proposal, however, did not include an increase in funding for Housing Opportunities for People with AIDS (HOPWA), a particular priority of advocates.

Biden’s proposal also includes an increase in funding for the Indian Health Service to better address HIV and Hepatitis C by about $5 million.

In line with these efforts, the Administration unveiled the financial cost of a national Hepatitis Elimination Program (HEP): $11 billion (over 10 years). Now, effort has been in the works for a while, benefitting from a boost of interest from advisor Francis Collins. Biden’s team is already working hard blunt the shock of the request, arguing that making the investment now would, in that same timeframe, actually only amount to about $5.2 billion, thanks to savings realized by a reduction of costs associated with treating long-term impacts of Hepatitis C, including certain cancers. The program would aim to save 100,000 lives by 2050, if goals are achieved.

Of these ideas, HEP likely has the best chance of getting closer to its goal (though, not nearly as close as the Administration or advocates might like), in part, because the idea is largely modeled after cost savings realized in Louisiana and Washington after implementing a “subscription” model of drug purchasing for public programs. While these programs have indeed saved monies for those states, and would do so for the country at large, and increased the number of people accessing curative direct acting agents, they have also stagnated in reaching their goals. That lack of progress after making a giant leap can be attributed to several factors, of which both Ending the HIV Epidemic and a national Hepatitis Elimination Program will face.

Let’s break those factors down real quick by highlighting the Hepatitis C program, which focuses on medication cost and access among at-risk communities near exclusively.

A report from the CDC released last year found just 1 in 3 insured patients who need access to curative treatment for Hepatitis C received it. These are patients whose coverage is already guaranteed. Barriers included payer administrative burdens, including prior authorization requirements, and, likely most importantly, providers just not…providing; not screening, not referring patients for diagnostic testing, not prescribing curative medications for patients (hoping the virus will clear on its own), and not following up to ensure sustained virologic response. And that’s for well connected and engaged patients. Hepatitis C thrives among populations which are routinely hardly reached – people who use drugs, poorer populations, imprisoned people, persons experiencing homelessness, a whole host of folks who need a whole awful lot of help. While the Administration’s proposals would look at encouraging using local pharmacies as points of access and investing in innovative screening tools, like rapid tests, none of those things speak to identifying and treating people most affected by Hepatitis C and HIV. And none of those things would incentivize private providers to increase their frequency of screening for and treating Hepatitis C and HIV.

These lofty goals are admirable. And frankly, they’re achievable. We would also need these tools already mentioned, certainly. But without baseline investments in making HIV and Hepatitis C screening a standard of care, a mandatory inclusion in annual wellness checks, requiring prisons and jails to screen, report to state health departments, and provide curative care on both intake and release, without ensuring clinics are sufficiently funded to have staff to do street outreach, we’re gonna keep missing the mark. Reaching communities that are hardly reached means spending more money per patient in order to reach each patient, not less.

So yes, this is a great start. Yes, these investments need to be made. Yes, this is a great starting point. No, it’s not enough.

Advocates would be well-served to fine tune messaging that thanks allies in power for supporting these tools while also emphasizing that we haven’t yet used all of the tools still in our toolbox. We need to continually re-invest in the foundation of this work while also growing and innovating. Medication is but one tool and without the support for patients to even get to a provider who is willing to screen and treat them, all the medication in the world won’t help.

We need to invest in our own “Yes, and…show me your values…” as we meet with each other, our partners, law makers, policy makers, and the Administration.

Hepatitis C Medicaid Access Dashboard Provides 2023 Updates

In February, the Hepatitis C State of Medicaid Access project, operated by the Center for Health Law and Policy Innovation of Harvard Law School (CHLPI) and the National Viral Hepatitis Roundtable (NVHR), updated snapshot of the variety of restrictions and barriers to care prevalent in state Medicaid programs regarding accessing life-saving Hepatitis C (HCV) treatment. The project has been working to expand access to HCV treatment since 2014 and is a ready tool of state advocates seeking to end discriminatory program policies.

Last year, the project updated the monitored metrics to adjust to successes in advocating for policy and program changes but to also begin monitoring new ways programs are finding to restrict access to and coverage of care. Evidenced by the 2021 snapshot report citing changes since 2017, including 32 states having eliminated or reduced fibrosis restrictions, 21 states having loosened sobriety restrictions, and 25 states having scaled back provider restrictions, the 2022 report began tracking retreatment restrictions, disparities between fee-for-service (FFS) access and managed care organizations (MCOs) access policies, and “additional restrictions” including time-based lab requirements, past adherence to other prescription medications, and policies which prohibit replacement of lost or stolen medication. Restrictions not tracked yet but may be in the future include monthly prescribing limits and specialty pharmacy requirements.

The 2023 update notes that since 2022, seven states removed prior authorization requirements for most patients, no changes in fibrosis restrictions (with Arkansas and South Dakota being the only states remaining with this policy), six states having removed substance use restrictions, one state (Nevada) having removed prescriber restrictions, three states removing re-treatment restrictions, and, cumulatively, three more states have addressed disparities in FFS and MCO access to HCV treatment. Similarly, the 2023 snapshot also includes some nuanced updates with regard to prescriber restrictions, now noting a lack of restrictions for a “simplified” or “initial” treatment offering in Hawaii, Kansas, Kentucky, Utah, and West Virginia. Additionally, the FFS versus MCO access portion introduced layers of understanding, segregating out states which do not use MCOs from the overall graphic. While Colorado, Ohio, New York, and West Virginia addressed the issue of additional restrictions or a lack of transparency, Texas took a step backwards and found itself being added to the list of states with a lack of clarity and additional MCO restrictions on HCV care. One hallmark metric of the project also received a “facelift” by introducing a “grading” system for each state’s prior authorization policies, ranking from “A+” to “F”; 9 states received an A+ for having no prior authorization requirement for most patients, 12 states received an A for having removed prior authorization requirements for most patients and having minimal restrictions, 11 states received a B for removing prior authorization requirements for most patients with some restrictions, 12 states received a C for requiring all patients to obtain prior authorization though having few restrictions on accessing care, 6 states received a D for requiring prior authorizations for all patients with “many restrictions”, and 2 states received an F due to requiring all patients to obtain prior authorization and having “harsh” restrictions.

The snapshot and grade systems have proven to be extraordinary tools in targeting advocacy, including litigation, to improve access to curative HCV treatment for Medicaid patients. Recognizing access to care is not granted, even in public payer programs, also allows advocates and policymakers to make more conscious policy decisions and empower practical programmatic design aimed toward benefiting highly affected communities.

Areas of additional support are necessary as payer policy is but one barrier to care. Advocates can and should seek changes which address provider discrimination, incentivize screening by way of establishing HCV screening as a standard of care or otherwise covered in a state’s “essential health benefit” design, and encouraging policymakers to address disparities in screening and treatment in carceral settings. Addressing HCV in carceral settings might start by requiring state prisons and local jails to report these metrics to state health departments on a regular basis, rather than hiding data behind jail systems which require and are often slow to respond to public records requests.

Much work remains and we’re ever grateful to our friends over at CHLPI and NVHR for their astounding work.

HCV ‘Netflix’ Model Reveals Price Isn’t the Biggest Problem

A recent article published to STAT News offers a detailed view on how in 2019, Louisiana and Washington State invested in the headline making, flashy deal of the century. It involved an unlimited supply of direct acting agents (DAAs) known to cure Hepatitis C (HCV) for the price of a standard “subscription” fee. Now, it wasn’t a $9.99 per month, endless video watching gig, but rather thousands of prescription fills per month meant to address the needs of each state’s Medicaid program and correctional facilities. However, such penned deals are estimated to have already saved the two states hundreds of millions of dollars. The subscription model is exciting, STAT reports the Biden Administration wants to build a similar program on the federal level. So that should solve the problem, right?

Not so fast! The data, and the experts, offer a more cautious tone.

A heady launch led to incarcerated people, who had previously sued for access to these curative treatments, finally received them. The states moved to reduce the “utilization” restrictions, like prior authorizations or requirements to have a specialist supervise the care. But that steady progress slowed to a trickle, and signs exist that the progress is already being lost.

2020 brought well-known disruptions in care, including reductions in screenings in hospital settings, and strained prison and jail staffing. And while the COVID-19 pandemic’s crisis phase may provide somewhat of a pass, it doesn’t explain all of the losses and slow return to focus on each state’s plan to eliminate HCV.

What’s at the core of the elimination efforts missing their mark? The planning and implementation of the program hinged on the idea that drug cost was the primary issue as to why people weren’t accessing this curative treatment. Turns out, even if the drug is free to patients and affordable for states, there’s more to care than cost, especially in public health. Despite hundreds of millions in saved dollars, neither state set aside enough (or any) of those projected savings to bolster provider education, invest in the human capital necessary in health care entities serving the most affected public (like federally qualified health centers), or reimbursement for “street medicine”, or innovative program designs, or – as especially is the case in Louisiana – ensuring state health departments have the staff dedicated toward HCV elimination.

Let us take a second to consider that last point. Louisiana’s STI, HIV, and Hepatitis Program is in pretty desperate shape. A long list of job openings reflects the fact that much of the program’s staff are subcontractors with those contracts spread across three different entities, a result supposedly of former Governor Bobby Jindal’s efforts to gut the program entirely, the program can’t attract or retain talent because wages remain ridiculously uncompetitive and, in instances where staff is offered promotions, they have to consider the trade off of losing their health benefits and accrued vacation days for a short period of time if that position is being held under one of the other three contracts. With that kind of tangled web to navigate, no wonder the state is falling behind. On social media, some state legislators have openly mocked the Louisiana Department of Health asking for budget increases. None of that touches the lack of physical access points of care patients need in more rural parts of the state – sometimes driving hours to find a provider to treat their HCV – or the failure of jails and hospitals to universally implement the screening elements of a successful elimination plan.

With the Biden Administration already struggling to get Congress to fund similar subscription plans for COVID-19 testing and treatment and flat out refusal from certain Senators to fund the Centers for Disease Control and Prevention’s sexually transmitted infections work despite data showing that under no uncertain terms the need exists, is there any real hope an appetite exists for similar funding to eliminate HCV in the United States?

One thing is clear, the cost of medication a payer sees (public or private) is not the biggest barrier to care for patients. Indeed, few patients care very much at all about what a payer’s costs are – patients care what their costs are and that includes costs not readily recognized by payers (like costs associated with time off work due to narrowed provider networks), or the time it takes providers to build trust in highly affected, highly marginalized communities. In fact, if policymakers wish to make the great investments necessary to eliminating HCV, they can start with sensible steps like requiring and enforcing hospitals to implement opt-out screening activities by way of rule making or legislation directing HCV screening to be a standard of care and integrated into the state’s essential health benefits benchmarks. Similarly, those same policymakers could require and enforce implementation of universal screening in all carceral settings or introduce legislation which requires departments of corrections to provide DAA to all incarcerated people diagnosed with HCV, regardless of cirrhosis status. States could require commercial health plans to cover DAAs at no cost sharing or require that all covered entities in that state charge a flat dispensing fee for DAAs (recognizing abusive dispensing fees for DAAs necessarily reduce the dollars available to support public health programming). States could dig into consolidation of access points to care to the exclusion of entire geographies hard hit by disparities.

There’s so much more to “access” to care than what a payer negotiates with a drug manufacturer and focusing exclusively on the issue of drug pricing. Without robust planning, reinvestment of “savings” into the logistical supports – including competitive wages and benefits packages for labor needs – necessary to feed the roots of this tree, all we’ll be left with is the low hanging fruit and rotten wood. And if we’re not careful, efforts at Ending the HIV Epidemic might end up looking much the same.

Blame Payers for Only 1:3 Patients Receiving HCV Cure

On August 9th, the Centers for Disease Control and Prevention (CDC) provided an early release of a Morbidity and Mortality Weekly Report (MMWR), detailing the massive inequity between insured patients in need of curative Hepatitis C (HCV) treatment. By evaluating the HealthVerity claims and encounters database, researchers were able to identify particular patient characteristics, including payer type (private, Medicaid, and Medicare), sex, race, and age. Of particular note, assessment included recognition of various restrictions some state Medicaid programs impose on patients.

Importantly, the CDC notes that about 2.2 million people in the United States are living with an HCV diagnosis and 14,000 people die of HCV-related conditions annually. These deaths are largely preventable thanks to the development of curative treatments through direct acting agents (DAA)s. The analysis also cites previous research finding that providing timely, curative HCV care reduces costs to payers (and their sponsors) compared to costs of denying care. This remains true even when patients experience reinfection or treatment interruptions. Essentially, a cornerstone of public health is affirmed in curing patients of HCV, patient quality of life and health, engagement in society, and the economic benefits thereof are well-served when patients have ready access to life-saving treatment. This all emphasizes why the disparities displayed in the findings of this report are unacceptable and must be addressed with urgency.

Generally, for inclusion in the analysis, patients needed to be enrolled in health insurance coverage consistently just before and during the time period used in the paper. Of the unique patient files evaluated, just under 48,000 qualified for inclusion in this analysis. Medicaid and patients with private insurance saw about the same number of HCV screenings performed, however, Medicaid patients were more than twice as likely to receive an HCV RNA test whereas Medicare patients were most likely to receive an HCV RNA test than the other two payer types with rate of HCV positivity was highest among Medicaid patients. Of Medicaid patients qualified, more patients lived in states with treatment restrictions (47%) than in states without restrictions (38.8%). Overall, patients enrolled in private care were most likely to initiate DAA treatment inside of the following year (35%) and Medicaid patients were the least likely (23%). Treatment initiation was most likely to occur within 6 months of diagnosis. Critically, there did not seem to be a massive racial disparity within a particular payer type, except those patients who selected “other” or were missing racial information in their claim. For Medicaid patients, the drop was significant (19% and 20% respectively). Patients enrolled in Medicaid in states with program restrictions were 23% less likely to initiate treatment than Medicaid patients in states without restrictions.

The authors urge some caution because the qualification for inclusion required a long period of continuous insurance enrollment and did not include uninsured, incarcerated people, or people who receive coverage through other public payers (Veterans Administration or AIDS Drug Assistance Programs). The CDC expects treatment initiation for people who experience disruption in insurance coverage are less likely to initiate curative HCV treatment, in general. And the data provided has no ability to inform the “why” behind delays in initiation or failure to initiate curative treatment.

The data did not mention how the COVID-19 pandemic may have affected claims, treatment initiation, screening and testing, or even insurance enrollment during the period of time included in the assessment.

The Center for Health Law and Policy Innovation at Harvard and the National Viral Hepatitis Roundtable issued a lengthy statement urging policymakers to take note of the report. The groups highlighted their annual report on barriers to care in state Medicaid programs, Hepatitis C: State of Medicaid Access, pointing toward to work as a guidepost for reducing barriers to care and increasing patient access. The report has recently undergone an update in metrics assessed as progress has been made on fronts regarding issues raised in previous reports. Notably, the updated metrics include an “other restrictions” category to include restrictions on treating reinfections, requirements in on medication adherence (including adherence to medications not used to treat HCV), and refusal to cover lost o stolen medications. That last piece needs note because the state of Florida is one of those (9 in total) programs which limit coverage for lost and stolen medications and these barriers, under issues of natural disasters, institute yet one more barrier to care and burden when patients can afford disruption the least – such disruptions also impact adherence, creating what can amount to an unwinnable situation for many Medicaid patients.

Significantly, the CDC’s report opens with noting that all of this is preventable. Advocates should consider pressing this report with their federal and state electeds and policymakers, emphasizing these findings represent the “best” of circumstances, in terms of coverage, and many of their constituents (and ours) do not enjoy the best circumstances.

Improving Liver Health for People Who Inject Drugs

A recently published study in the Annals of Internal Medicine found that providing Hepatitis C treatment to people who inject drugs (PWID) showed significant improvement in liver health outcomes when provided with community-based access to care and treatment. The study, which drew its cohort from Baltimore and collected data from 2006 to 2019, found a particular value to participants in low-barrier access to care – a mainstay of harm reduction advocates.

The qualifying condition for participants was a chronic HCV diagnosis, with the majority of participants being Black, assigned male at birth, and not having an HIV diagnosis. Within the last 6 months of the participants’ lives prior to study enrollment, 54% had injected drugs and 27% were on methadone. 56% of participants also scored as having had severe, harmful, or hazardous alcohol use. The initial rate of cirrhosis was 15%, rising to 19% in 2015 and dropping dramatically in 2019 to 8%, with the rate of detectable HCV RNA reducing from 100% in 2006 to 48% in 2019. Self-reported treatment also increased from 3% to 39% across the study period. Some of the most significant findings of the study were specific to broader outcomes – those with undetectable HCV RNA were 72% less likely to develop cirrhosis and were at 46% lower risk of all-cause mortality. While 430 of the participants died across the span of the study, 394 had chronic HCV and 36 had no detectable HCV RNA. 29% of those deaths were categorized as from drugs or trauma, 41% from chronic illness, and 6% from liver disease/cirrhosis.

The study itself did not depend on distribution of treatment to patients but rather, it sought to assess how patients engaged in care in community-based settings and what accessing services through these settings means for patient health outcomes. The study’s findings aren’t particularly surprising for anyone familiar with providing services to communities which are often marginalized. Indeed, for communities and patients experiencing poverty or living in health care deserts, also coinciding with red-lined neighborhoods and thus associated with Black communities, access to “traditional” health care settings is limited or not meaningfully existent. Trust of traditional health care and even public health services is equally limited due to historical traumas, including forced sterilization, concerns for law enforcement engagement, and – perhaps most directly – due to provider bias. Community-based, low-barrier care in light of these realities and lived-experiences are simply…more welcoming.

In recognizing a sense of welcoming, observers should also recognize the sense of safety patients to these settings feel – that trust in tangible for patients. It’s also important to recognize a particular failure in federal funding focuses in entities that may claim being based in a particular community but are not necessarily required to hire providers or staff from the service area or served populations. Indeed, during a recent O’Neill Institute call, this distinction was of particular complaint. Funding is typically awarded to larger entities rather than smaller ones and holds no particular requirement for staff to be reflective of the patient population. For those larger entities, they tend to also be stuck in programming with limited creativity, are explicitly tied to specific clinical outcomes, and extraordinarily strict and onerous reporting requirements. Those requirements can and do translate into administrative barriers for patients and limit the creativity that may also translate less directly or immediately to measurable health outcomes. The complaints were broad, generally stating a need to take a more diverse approach that looked at longer-term investments into patient health through relationship building.

Those relationships are critical to the success of patients and introducing the ideas behind “harm reduction”. Another barrier to successful harm reduction can be found in particular state and federal policies which may run contrary to the best practices identified by academics and advocates. In this, the details matter. For example, most “good Samaritan” laws maintain a carve out of exception for drug dealers in reporting overdoses – even if they wanted to help, they could be prosecuted for homicide if a person dies, discouraging intervention from the course. For states with syringe exchanges (now facing conservative backlash by way of moralizing substance use rather than viewing substance use as a health condition), many still maintain paraphernalia laws which means patients engaging with syringe exchange programs can be arrested and charged either going to or coming from accessing services at syringe exchange sites.

Community Access National Network’s HIV-HCV Co-Infection Watch monitors certain state-level harm reduction measures in an effort to provide a resource to advocates and our Annual Monitoring Report discusses these nuances. Advocates know well the positive health outcomes for patient and communities when public health programs are designed with long-term investments are made and comprehensive approaches are taken. State and federal law and policy makers would do well to reconcile the conflicts between these and strive to achieve a policy environment which fosters the development of creative, safe, low-barrier care and reduces risks to people who inject drugs.

Treatment Restrictions Hampering Hep C Harm Reduction Efforts

In January, Harvard’s Center for Health Law and Policy Innovation (CHLPI) and the National Viral Hepatitis Roundtable (NVHR) issued their 7th update to the Hepatitis C: State of Medicaid Access report. Originally published in 2017, the report seeks to evaluate and document the nuances of Hepatitis C treatment access in state Medicaid programs and was borne out of the payer originated barriers instituted after curative direct acting agents (DAAs) came to market as concerns over cost rose, especially in light of the fact that a patient being cured does not mean they cannot be re-infected and the most at-risk population for contracting HCV are drug users. The combination of moralized policy making and fiscal fears set the stage for Medicaid to offer curative HCV treatments as a “yes, but…” situation.

Medicaid coverage of treatment came with layers of restrictions on patients and providers alike. From more common utilization management practices, like prior authorizations, to restrictions in who can access treatments (sobriety and fibrosis requirements) and requiring patients to visit a specialist in order to receive coverage (when a primary care physician should be able to manage the necessary care), barriers abound. Harm reduction advocates rightly pointed out refusing treatment coverage worked against best practices in interrupting HCV chains of transmission. Indeed, the American Association for the Study of Liver Diseases has strongly discouraged sobriety requirements because doing so artificially inserts barriers to care and harms public health efforts to eliminate HCV, stating:

… there are no data to support the utility of pretreatment screening for illicit drug or alcohol use in identifying a population more likely to successfully complete HCV therapy. These requirements should be abandoned because they create barriers to treatment, add unnecessary cost and effort, miss an opportunity to decrease HCV transmission, and potentially exclude populations that are likely to obtain substantial benefit from therapy. Instead, scaling up HCV treatment in PWID is necessary to positively impact the HCV epidemic in the US and globally.

The pushback against the moralized argument, which frames drug users as “unworthy” of receiving potentially life-saving care, is that people who use drugs are still patients and we don’t get to tell patients how to prioritize their care based on a payer or provider’s biases. Just as providing gender affirming care results in improved health outcomes in transgender people living with HIV, providing people who use drugs with the medical care they need to cure HCV improve the behavioral health factors that contributed to drug use in the first place.

CHLPI and NVHR’s work has contributed to awareness of these policy issues, with the updated report being used as an effective tool in advocacy for removing these unethical restrictions on accessing HCV treatments. Since the 2017 report, 33 states have eliminated or reduced their fibrosis requirements, 29 states have eliminated or significantly relaxed their sobriety requirements, and 28 states have reduced their qualifying prescriber requirements.

Similar qualitative evaluation of other “harm reduction” policies, should be done to consider how these policies may potentially work against the goals of why they were instituted in the first place; including but not limited to Good Samaritan laws (where carve outs for those reporting over doses may result in the reporter being charged with a crime, rather than protected for seeking help) and “lock-in” laws and policies (where a patient may not be allowed to seek a different pharmacy or provider). In each of the two examples, people who use drugs are discouraged from engaging with public service personnel by disempowerment and threat of criminalization, risking either losing a patient in care or losing a life.

The mark of quality policy making, much like the mark of good science, is being willing and able to consider changing things when the facts of a given situation change or the available information changes. If we are to meaningfully invest in harm reduction policies at the intersection of drug use and HCV, we have to get a handle on what’s working and what’s not. And we have to learn not to repeat our mistakes in the coverage restrictions finally falling out of favor.

How One FQHC is Advancing Health Communication

Earlier this month, new outlets got a hold of a local (to me) treasure: NoiseFilter. Local health heroes, Dr. MarkAlain Dery and Dr. Eric Griggs, have been hosting Noise Filter since the beginning of the COVID-19 pandemic as an innovative way to educate the public about pressing health issues. The show started as a podcast, moved to live streams on Facebook, and has recently found a niche in animated shorts designed to engage and entertain patients. One of the latest episodes, titled Test, Treat, Cure, focuses on explaining Hepatitis C and curative treatments.

Before we go further, you can check out other Noise Filter animated videos here and you really should. They’re fun! At a recent virtual event aimed at educating stakeholders on the issue of HIV criminalization, after reviewing the science behind Undetectable Equals Untransmittable (U=U) and other access to care issues, Dr. MarkAlain played this episode for the audience. The audience happened to include Centers for Disease Control and Prevention Division of HIV Prevention Director, Dr. Demetre Daskalakis, who may or may not have chair danced with the end of the video. They really are that exciting!

This isn’t Dr. MarkAlain’s first foray into utilizing broadcasting platforms to reach patients as audience members. In 2014, the good doctor helped found local radio station WHIV (102.3FM). Staffed by volunteer hosts and DJs and focused on issues of social justice, human rights, and community health, WHIV titles itself as “…not a radio station with a mission…a mission with a radio station.” The station’s programming digs into issues of policy, politics, faith, entertainment, and more.

Both Doc Griggs and Dr. MarkAlain and both programs are tied to one of Louisiana’s largest Federally Qualified Health Center networks, Access Health Louisiana. AHL is actively involved in the state’s health planning activities and has been one of the mobile testing providers even before the COVID-19 pandemic and was one of the state’s first at-home testing providers (for HIV screenings), positioning the entity well in terms of already having infrastructure in place to mobilize and having Doc Griggs’ astounding communications talent for breaking down complex health issues, setting patients at ease, and empowering communities to activation makes the entity accessible and flexible in meeting the needs of served communities.

In many ways, both Noise Filter and WHIV seek to speak to patients as whole people, with whole lives, living in whole communities.

We need more of that. We need more of this.

2022: New Beginnings, New Changes

The Community Access National Network (CANN) ushers in a new beginning with the 2022 New Year, evidenced not only by the changing of the guard with our new President & CEO, but also with some important programmatic changes with our organization. We felt it important to share these changes with you.

Our weekly blog, previously branded as the HEAL Blog (Hepatitis Education, Advocacy & Leadership), is being repurposed to serve our broader mission “to define, promote, and improve access to healthcare services and supports for people living with HIV/AIDS and/or viral hepatitis through advocacy, education, and networking.” As such it is now the CANN Blog, and its areas of interest will focus on HIV/AIDS, viral hepatitis, substance use disorder, harm reduction, patient assistance programs (PAPs), Medicare, Medicaid, and the ongoing Covid-19 pandemic and its impact on public health. In keeping with the desire to monitor broader public health-related issues and appropriately engage stakeholders, our CANN Blog will be disseminated to a larger audience. Therefore, some of you may notice one more email in your inbox each Monday morning since we’re employing our general listserv to share the blog posts. It is our hope that you’ll deem the added email of value and thus maintain yourself on our listserv.

Additionally, our acclaimed HIV/HCV Co-Infection Watch will also be shared with our general listserv. But don’t worry, it only means one additional email each quarter! The HIV/HCV Co-Infection Watch offers a patient-centric informational portal serving three primary groups - patients, healthcare providers, and AIDS Service Organizations. The quarterly Watches are published in January, April, July, and October.

In 2022, our Groups will also be more active. Since 1996, our National ADAP Working Group (NAWG) has served as the cornerstone of CANN’s advocacy work on public policy. Whereas NAWG will continue to engage our HIV/AIDS stakeholders with monthly news updates, we will also convene periodic stakeholder meetings to discuss important issues facing the HIV community. Likewise, our Hepatitis Education, Advocacy & Leadership (HEAL) Group has served as an interactive national platform for the last decade on relevant issues facing people living with viral hepatitis. Periodic stakeholder meetings to discuss important issues facing the Hepatitis community will now complement the HEAL monthly newsletter. If you would like to join either the NAWG or HEAL listserv, then please do so using this link.

CANN will also launch its 340B Action Center this year. It is designed to provide patients with content-drive educational resources about the 340B Drug Discount Program and why the program matters to you. The importance of the 340B Program cannot be under-stated, and CANN remains committed to taking a balanced “money follows the patient” approach on the issues facing the program and advocating for needed reforms.

Finally, like most advocacy organizations, CANN is constantly evaluating whether it is safe (or not) to host in-person stakeholder meetings. Covid-19 has changed the advocacy landscape. Over the last two years our two signature meetings (Community Roundtable and Annual National Monitoring Report on HIV/HCV Co-Infection) have been hosted virtually, rather than in-person. CANN is taking a “wait and see” approach on how best to proceed in 2022 with these events. We will keep you apprised of our decision.

As we close the door on 2021 and open it for 2022, CANN looks forward to working with all of its community partners, industry partners, and you!

2021: A Year in Reflection

The end of 2021 is upon us and that makes this a timely opportunity to reflect on the work by the Community Access National Network (CANN). During an exceedingly busy news cycle, we have published fifty blogs (including this one) on a variety of topics ranging from the latest on policy and regulatory issues, as well as some personal perspectives. Our HIV-HCV Coinfection Watch and our Annual Monitoring Report tracked Hepatitis C (HCV) therapies covered under the State AIDS Drug Assistance Programs, Medicaid, Veterans Administration, as well as patient access via patient assistance programs, and other relevant news items affecting our patient community. We also conducted a community roundtable seeking to highlight the impacts of Covid-19 on public health programs aimed at addressing HIV, HCV, and substance use disorder (SUD).

Notably, CANN published the following six-part series designed to educate patients on various aspects of the 340B Drug Discount Program:

·        A Patient’s Guide to 340B: Why the Program Matters to You

·        A Patient’s Guide to 340B: Why Transparency Matters to You

·        A Patient’s Guide to 340B: Why Accountability Matters to You

·        A Patient’s Guide to 340B: Why the Decline in Charity Care Matters to You

·        A Patient’s Guide to 340B: Why the Middlemen Matters to You

·        A Patient’s Guide to 340B: Why Program Reform Matters to You

With Congress engaged in high-conflict communication, to abuse a euphemism, navigating public policy developments and pertinent issues to patients can be challenging. CANN remains committed to being an essential source of two-way communication, information, and education wherein patients write the narrative driving policy reforms and priorities. In this, we are ever grateful to the patients and caretakers who have engaged with us at every turn. Your stories matter and you are not alone in your experiences.

The diverse partnerships behind this work are critical to our success and as we end the year, we want to offer our gratitude to these essential partnerships, ranging from other patient advocacy organizations, public health associations, and industry partners.

The issues affecting our public health space of patient advocacy have not relented this year. Covid-19 has only emphasized the need to ensure these programs are effective and efficient while also highlighting the existing weaknesses and strengths of these programs. To be clear, the structural and pervasive drivers of health disparities have been named; racism, sexism, classism, ableism, and all other biases which reflect a moral justification for out ethical failings must be addressed in tandem with policy changes and adequate public health program funding in order for us to succeed in these fights for patient lives. Health equity cannot be meaningfully segregated from the policy mechanisms in which these disparities have survived in the face of another pandemic – when our collective awareness of these inequities and leverage to progress on these issues should have been their strongest and yet were not.

It’s with these things in mind, we want to leave you with the enduring sentiment that next year offers us yet another opportunity to approaches these challenges with fresh eyes and fresh ideas. We are indeed stronger together and we sincerely look forward to working with you all to move closer in realizing a world of greater access to care, fewer and smaller health disparities, and, ultimately, a more fair and loving environment in which to live our lives and raise our families.

Author’s note: I often end certain professional meetings with telling my colleagues “Love ya’ll”. It’s a sentiment I mean to depths of my soul. I am fortunate to work with some of the most amazing people in the world – folks who share an unbridled commitment to improving the lives of those around them. It’s from this same space I wish to offer each of you reading this a moment to breathe and the same open heartedness. I want to leave you all with a short story that has shaped me in more ways than I can count, The Perfect Heart, and an encouragement to tell someone you love them as soon as you can. May this next year be gentler with us all and find us giving away more pieces of our hearts.  

FDA Move Aims to Diversify HCV Test Maker Market, Reduce Regulatory Burden

On November 19th, the Food and Drug Administration (FDA) released a pair of orders affecting Hepatitis C (HCV) antibody screening and diagnostic tools. The move was announced as a proposed order in April 2020 with a total of 13 comments on the proposed orders, including the National Association of State and Territorial AIDS Directors (NASTAD), Hawaii and Washington state Departments of Health, the National Hepatitis Roundtable, and one of the current leading device manufacturers, Abbott.

The final orders reclassify already existing screening and confirmatory blood and plasma testing while also changing the name of acknowledged name of the technology in use from “assay devices” to “tests”. The move is anticipated to reduce the burden in applying for regulatory approval of new tests but also require “special controls” to ensure the quality of testing technologies on the market continue to meet the high safety and accuracy standards they currently meet.

Of note, the FDA considered the impact the new final orders would have on public health initiatives, specifically the National Viral Hepatitis Strategic Plan.  Additionally, Abbott’s support comment was relatively brief and contained only the concern for possible product code labeling limitations for potential technologies; suggesting the FDA take a similar approach as taken to combination antibody and antigen testing with regard to HCV as with HIV testing. Abbott’s recommendation in the comment was to merely name the technologies “serological” tests rather than limiting application based on the mechanism of action in the test as both the proposed and final orders did.

NASTAD’s comment highlighted the difficulty in current surveillance efforts as confirming an acute or active HCV infection is a two-step process, of which, the organization claims few providers or patients follow through. NASTAD drew direct and natural and logical conclusions from the Centers for Disease Control and Prevention’s (CDC’s) Viral Hepatitis Surveillance Report, highlighting the public health risk HCV poses and the barriers to more effective surveillance efforts, including the cost and regulatory hurdles for new screening technologies to enter the market. The public health interests commenting requested the FDA consider expanding the final rule to include potential future technologies like over the counter (OTC) antibody tests or screening technologies based on body fluids other than blood and plasma or combination testing technologies targeting multiple types of viral hepatitis or HCV-HIV combination tests. The FDA’s response to comments in the final orders stated the new final order could not go beyond the scope of existing technologies and, as such, would not be able to change the approval pathway for new or emerging technologies.

While the orders represent an encouragement for manufacturers to enter the existing technologies market with regard to HCV screenings, diversifying the field, the announcement does not affect developing or new technologies and the pathways to approval those potential products will need to navigate.

Where Public and Private Payers Fail, Patient Assistance Programs Step In

During Community Access National Network’s Co-Infection Annual Monitoring Report, hosted during this year’s SYNC Conference, in reviewing Hepatitis C (HCV) treatment coverages offered by state Medicaid and State AIDS Drug Assistance Programs (ADAPs), I stated “ADAPs play a critical role even in Medicaid expansion states. With the cost of medications for both HIV and HCV, even making just about the Medicaid threshold can create a catastrophic gap in patient financial stability. Given the distinct exposure risks shared for both disease states, ADAP advocates should consider the advantages of their programs to fill this need.” And…

Earlier this year, I wrote a guest blog for ADAP Advocacy Association regarding the funding situation for Georgia’s AIDS Drug Assistance Program in light of shortfalls due to COVID-19. While Georgia has since enjoyed the benefit of astounding state advocates’ work, a hole in the program remains. At the bottom of Georgia’s most recent ADAP formulary a notice reads as follows: “Georgia ADAP Hepatitis C Program is currently on HOLD until future funding is available. Please utilize Patient Assistance Programs (PAP’s) for Hepatitis C medications.” Georgia wasn’t the only state to consider ceasing coverage of HCV medications, Texas did as well, though Texas has since added a single direct acting agent back into their ADAP formulary. In discussing the state’s funding shortfalls earlier this year, state representatives mentioned to providers referral to patient assistance programs in order to meet patients’ needs.

The summation here is publicly funded programs are not always aptly designed to meet the needs of vulnerable populations. Indeed, Harvard’s Center for Health Law and Policy outlines barriers to care instituted by public payers, like ADAPs and Medicaid programs, in an annual report. These barriers largely mirror the barriers to care instituted by private payers, wherein private payers argue these are necessary “cost containment” measures (otherwise referred to as “utilization management”). However, for patients, these “cost containment” measures largely amount to “care containment” measures and, frankly, do little more than push patients out of care through administrative burdens, commonly manifested as lengthy appeals processes or requirements for sobriety.

When public and private payers fail patients by refusing coverage of HCV treatments, they also fail our public health goals, perpetuating preventable illness and death. In the space where payers deny coverage and where people cannot afford coverage due to premiums or deductibles or being too high or where patients simply can’t afford insurance coverage and can’t access public programs, patient assistance programs step in. Patient assistance programs may be run and funded by medication manufacturers or by community-based funding programs and navigation information tools.

CANN’s quarterly Co-Infection Watch monitors HCV specific patient assistance programs for status and limits, in order to make identifying resources easy for patients and advocates reviewing the report.

While these tools are excellent tools of last-resort, they are limited and cannot be used as a substitute to sufficient public funding, regulation or legislation ensuring non-discriminatory plan designs, and adequate patient protections. Public payers have come a long way in abandoning caustic programmatic barriers for patients to jump through in order to access care and medication and private players have much farther to go. Regardless of circumstance, neglecting this critical medical intersection by way of foregoing HCV medication coverage is a public health and public payer program failure. All it does is kick a snowball down a hill. We’re already set to fail meeting our 2030 goals toward HCV elimination. We must do better to ensure this problem, at the very least, doesn’t grow.

HIV & Covid-19: A Story of Concurrent Pandemics

On September 20th, Johns Hopkins’ COVID data tracker totaled the “confirmed” (note: not “official”) number of deaths from COVID-19 in the United States to surpass 675,000 – or the estimated number of deaths in the US due to the 1918-1919 H1N1 influenza pandemic (colloquially called the “Spanish flu” because Spanish media were more willing to discuss the pandemic than most other countries). Forbes, STAT, and other large news outlets ran headlines like “Covid-19 overtakes 1918 Spanish flu as deadliest disease in American history” or included statements in their articles like “It was the most deadly pandemic in U.S. history until Monday, when confirmed coronavirus deaths overtook the death toll for the Spanish Flu.”

Which, as Peter Staley pointed out, isn’t factually accurate.

Image: Twitter.com - @peterstaley (Sep 20, 2021) “Um, HIV/AIDS?  700,000 U.S. deaths (and counting), according to the http://HIV.gov https://hiv.gov/federal-response/ending-the-hiv-epidemic/overview”

Staley would quickly admit COVID-19 would or already has likely overcome the death toll of HIV in the United States. While I agree with this analysis, I would add “for now”.

The very nature of HIV has made finding a “cure” or vaccine for the virus an oft sought after “holy grail” in pharmaceutical development. While that grail may have been snatched away by the attention COVID-19 is justly generating, this isn’t the first concurrent pandemic HIV has run alongside. The Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) both refer to the H1N1 influenza outbreak of the 2009-2010 flue season a “pandemic”. The problem of course isn’t just how deadly COVID-19 is, its’ how botched the domestic and global responses have been to the disease.

Viruses, after all, are opportunistic. They have a singular purpose: reproduce. As such, viruses thrive in environments – ecosystems, if you will – that are sorely neglected, lack coordinated responses, and are largely inequitable. But we knew that. We’ve known that with regard to global and domestic health disparities data for decades. As with personal health, emerging, urgent issues in public health reduce our capacity to address existing issues effectively.

As I mentioned in previous blogs, and has been recently noted by the Global Fund, COVID-19 has drastically reduced the efficacy of existing HIV, HCV, STI, and SUD programs. Even still, Global Fund’s report proves a rather interesting point – when meeting the demands of advocates for programs to provide patients with multi-month supplies of medications, meeting people in their own neighborhoods rather than in clinics, and providing at-home testing kits, communities can be activated in care at an exceptional level. Despite the COVID-19 pandemic raging, the needs of the HIV pandemic didn’t stop. And while meeting those needs faltered some (with 4.5% fewer mothers receiving vertical transmission prevention medications, an 11% drop in prevention programming, and a 22% reduction in testing services), in some areas meeting those needs thrived. Global Fund’s report found South Africa was able to increase the number of people receiving antiretroviral therapies by more than three times the baseline, even while fighting on two fronts.

Dr. Sioban Crowley, Head of HIV at the Global Fund, pointed out these program designs are not exclusive to HIV, “If we can keep 21.9 million people on treatment, we can probably deliver them a COVID test and a vaccine.”

Indeed, with the United States’ (and the world’s) response relying heavily on expertise gained in the fight against HIV, one can reasonably ask “If we know how to beat this, why aren’t we…just doing that?”

“That” being what advocates have long asked for: a more dedicated, equitable landscape and adequate support of our public health systems. As with COVID-19, a vaccine won’t “cure” us of HIV if the rest of the world cannot access it. As with HIV, if preventative services, adequate testing, and necessary education are not readily made available to people where they are, we will continue to fail in both fights. If we don’t wish to repeat the losses we’ve already experienced in the fight against HIV, then we cannot keep making the same mistakes of kicking the costs of these investments down the road and maybe, eventually “getting to it”.

As has been said many times through the latest pandemic, “the best time to do the right thing was yesterday. The next best time to do the right thing is today.” It’s time for us to do the right thing and stop allowing backbone public health programs to fall by the wayside in the face of the next emergency. Today, for the next few years, it’s COVID. We don’t need to “wait” for that to end. There’s two pandemics occurring, it’s time we act like it.

Veterans Linkage to Care: Perspectives on HIV, Viral Hepatitis, Opioids & Mental Health

Approximately 8 percent of the U.S. population are Veterans, numbering over 18 million Americans with most of them being males and older than nonveterans. But those demographics will change in the coming years, with significant increases in ranks among women and minorities. As a society, we tend to view these men and women formerly in uniform as larger than life figures capable of overcoming almost any odds. The reality, however, is there are numerous ongoing public health challenges faced by Veterans in this country once discharged from the military – among them HIV, Hepatitis C, opioid dependence, and mental health conditions. As a society, don’t we owe it to them to provide the most timely, appropriate linkages to care and treatment?

In 2019, there were 31,000 Veterans living with HIV seeking care within the Veterans Affairs (VA) healthcare system. Additionally, 3.4 million Veterans were eligible for HIV screening. Navigating the VA is challenging enough for our Veterans, but imagine doing so after first being diagnosed with a lifelong, chronic illness like HIV/AIDS? Although no longer a death sentence, Veterans need to learn how to steer living with HIV in what seems like a battlefield of complex bureaucratic systems, simply to start their care and treatment. For Veterans, staying connected to appropriate levels of care continues to be vital for many reasons.

For example, pulmonary hypertension – a blood pressure condition that affects the lungs and heart – is higher among Veterans living with HIV than in veterans who don’t have an HIV-positive diagnosis. What adds an extra level of concern is that Veterans with a CD4 count below 200 are also at higher risk of pulmonary hypertension, including Veterans who have viral loads higher than 500 copies per mL. Pulmonary hypertension within itself is a rare condition but that is exactly the reason why Veterans needs to remain linked to their healthcare providers. Some healthcare providers may not be actively probing for rare conditions like pulmonary hypertension and thus the condition and its possible progression will go largely undiagnosed. This further places into perspective the wide net needed in appropriate, timely HIV care and treatment that goes beyond taking antiretroviral (ARV) medication to achieve viral suppression.

Advances in HIV medicine – namely the introduction of the highly active antiretroviral treatment in 1996 – changed how people can live their lives after an HIV-diagnosis. Whereas people living with HIV who are virally suppressed have the same life expectancy as their non-positive counterparts, they’re also prone to age-related conditions and other co-morbidities, such as the previously discussed pulmonary hypertension. What this also means is that living longer, fuller lives also opens-up the door to emotional distresses.

Newly enlisted service members cycle through intense emotions when shifting from civilian life to the demands of military culture. Post discharge, Veterans can find themselves yet again cycling through acute reactions as they struggle to respond back into the reintegration of the everyday family and civilian life. As a result, studies have shown that incidences of ischemic stroke, the most common type, is more prevalent in Veterans who are HIV-positive dually diagnosed with depression in comparison to Veterans who don’t have a positive diagnosis without depression. This is significant because a common psychological effect of depression is isolation. Without proper linkages to care, so many human pathways of connectivity can begin to become severed. Positive behaviors and patterns begin to change, and this is a dangerous mental state to be in not only as a Veteran struggling with civilian life, but also maintaining the healthy and consistent level of care and treatment that is needed for Veterans living with HIV. It opens the door to poor medication adherence, decreased social networks, and increased likelihood of substance use disorder. These landmines are crucial markers to ensure Veterans living with HIV are kept engaged in their treatment plans. Likewise, all clinicians need to do the same by remembering to evolve with their clients to continue providing them with the services that they need and deserve.

Another silent threat facing both Veterans and nonveterans alike is Hepatitis C (HCV). The Centers for Disease Control & Prevention (CDC) estimates there are nearly 2.4 Americans living with HCV. It continues to remain a public threat to the general population, but it particularly relevant to address how the silent epidemic is impacting Veterans.

If left untreated, HCV can be fatal because it can lead to cirrhosis of the liver. Veterans experience chronic HCV at three times the rate of the general population, with 174,000 Veterans in active care within the VA system. So, what factors need to be considered by Veterans seeking testing and treatment options for HCV? After all, modern medicine continuously changes the landscape of the available medical treatment options, and the constant reevaluation can be overwhelming. Fortunately, newer HCV therapies have made it a little easier. A qualitative analysis of 29 Veterans who were looking into HCV treatment, 35 total factors were of interest were identified. Of this set of 35 attributes, the top reported were treatment efficacy, physical side effects, new antiviral drugs in the pipeline, liver condition, and psychological side effects.

While the report’s findings aren’t necessarily surprising, how they structured their analysis is important. The Veterans in this study were placed in one of three categories that identified their personal stage of change – which were contemplating treatment, recently declined treatment, and recently initiated treatment. Successful linkages to care involve acknowledging where clients are in the process because it helps to identify and structure a patient centered treatment plan. What is important to remember is that each stage of change is shaped by the personal lived experiences clients are currently experiencing. Some of these subfactors are important social systems that they interchangeably occupy like family, friends, work, religion, and perhaps other various community engagements. All of which can greatly affect the decision-making process when considering treatment. Clinicians across the board need to have a clear picture as to what their client’s value and integrate those value systems into the appropriate levels of care to maximize the effectiveness of their treatment.

This same study uncovered another point of interest that is worth mentioning. When it came to gender, 50% of women compared to 14% of men, reported having concerns with social attributes like stress on partnerships and stigma associated with a disease. Additionally, women also reported concerns about maintaining their privacy within the systems that they occupy. In some ways these results are not surprising given the long history of women being undervalued and overexposed within society. That said, what this does highlight is how the concept and execution of healthcare needs the integration of a vast interpersonal team across a diverse and all-encompassing platform that has the capability to target these pockets of influence.

Healthcare disparities, unfortunately, exist across a wide spectrum within our medical framework and the VA isn’t immune from it. For minority Veterans with hepatitis C, seeking treatment are faced with unique barriers. For example, an HCV-diagnosis is four times more likely among minority Veterans compared to the general population. The VA’s Office of Health Equity (OHE) has done some great work in eliminating health disparities among minority Veterans with HCV, including testing. Testing is made available to all Veterans who are enrolled in the VA; they have treated more than 123,000 Veterans, and successfully cured more than 105,000 Veterans. The VA’s vigorous approach to its mission has been met with great results as race and ethnicity proportions are being treated equally with no population higher than the other. Effective strategies like video telehealth, the use of nonphysician providers, and electronic data tools for timely patient tracking and outreach have allowed the VA to expand their services to better address gaps in care. Work like this is needed across VA systems and local communities to minimize the gaps that are all too often seen in minority groups especially when there are 50,000 Veterans who are undiagnosed for HCV.

Any discussion about linkages to care needs to address the risk association between Hepatitis C and opioids. Since 2010, there have been correlating spikes in both. According to the CDC, HCV cases have nearly tripled between 2010-2015, and during this time the growing use of opioids exploded thanks to OxyContin, Vicodin, morphine, and fentanyl.

Like the general population, substance use disorder can be an inherited experience for Veterans, sometimes exacerbated by the effects of military culture. As a result, 1.3 million Veterans experience levels of substance use disorder. A study by the VA Health System in 2011 indicated that Veterans, when compared to the general population, are twice as likely to experience death from an opioid overdose incident. The biggest leading factor in this is prescription opioid medication and it continues to increase. In 2005, 4 percent of service members reported misusing their prescription medication. Three years later, 11 percent of service members reported the same misuse. The challenge here is that military culture demands a high level of sacrifice, which often comes with potential risk factors like bodily injuries and exposure to traumatic events. Both can be a slippery slope. Physical injury begins to be a major factor almost immediately after enlisting. Service members are pushed daily to exercise and ushered through a series of combat drills that will no doubt include heavy equipment. The body has a great ability to adapt and strengthen itself but like anything else, it has its limits. If this sets the stage for a revolving door of service members in physical pain, the natural course of action would be to provide medication to offset these symptoms. And just like that, accessibility without effective evaluations become the gateway to opioid substance use.

In the same fashion, traumatic events can leave service members feeling disconnected from where they’d like to be both emotionally and physically. In military culture, perception of strength is reality and as such, seeking services for mental health is often challenging for servicemembers as they don’t want to appear weak, so they suffer in silence. But that is exactly the reason why work is needed to change this outcome. Military culture to a very large degree is unwavering. It needs to build soldiers and do that; it needs to condition enlistees. However, it would be beneficial if clinicians and doctors within military culture to incorporate better systems of evaluation when it comes to pain management. This would also need to extend into the various VA systems that service members have access to. Relationships and bonds are obviously built within military culture and their importance may be of great benefit when combating the negative effects of stigma associated with mental health trauma. Community programs can be fostered and guided by various ranking officers to establish a sub community where conversations of real-life experiences demonstrate that a soldier of any rank can be supported by the comrades and communities that they protect.

But accessibility is a two-way street. Clients should have the ability to gain access to healthcare to receive treatment for various medical concerns. Clinicians or outreach programs should be able to have access to community members that need a particular public health service. Syringe services programs (SSP) introduced in the 1980s, have been adopted by the VA system to reduce the harm for Veterans who inject drugs . Veterans who utilize SSP’s can receive substance use and mental health services with the VA including additional services through an SSP program like vaccinations and naloxone, which helps to prevent an accidental overdose. Veterans benefit from community-based programs like this even with the controversies that the program may still carry since its inception. This program has been proven effective in reducing transmission of disease like HIV and Hepatitis C. While this program isn’t stopping the use intravenous drug use, it does open the door for Veterans who may be in a place mentally to accept help. Programs like this are a great hub to access community members and have conversations about recovery services. Like most things in life, addiction is complex involving a multitude of factors that contribute to the addictive behavior. Drugs are the symptom, but the person is the real key to the solution within the equation. Lived experiences matter when looking at public health issues across the board. How people experience live greatly shapes how they decide to show up for it, especially in challenging times. If there are 343,000 Veterans who use illicit drugs, then effective and targeted programs need to be in place not only at VA systems but also in their surrounding communities.  One of the great aspects of SSP programs is that it targets Veterans by how they are currently living with a substance use disorder, and while strengthening community engagement through public service.

Military culture and trauma are often associated with one another, but it isn’t always linked to deployment. That said, combat-related post-traumatic stress disorder (PTSD) is quite prevalent among active-duty service members, as well as Veterans. For service members nearing active-duty discharge, a diagnosis of PTSD may change the status of their discharge, greatly affecting the outcome of receiving services from the VA. The term “bad papers” is used within military culture to signify that a Veteran has been discharged unfavorably. A status discharge of other than-honorable is essentially the kiss of death because it means that a Veteran will not be able to access services through the VA. What is interesting about this status is that it is given for felonies, those absent without official leave (AWOL), desertion and Veterans with drug offenses. The issue then becomes the consequent behaviors of Veterans struggling with PTSD who turn to substance use to cope and who then also begin to have behavioral changes which affects level of performance on all fronts. Veterans carry an immense sense of pride for their service, and rightfully so. They have stepped in roles that most people don’t have the courage to do so. As an evolving clinician, seeing a Veteran struggle with PTSD due to the natural climate of what their duty demands of them, and then being shut out of benefits that are crucial to their mental health is just unacceptable. Discharge review boards really need to reconsider the criteria for evaluating Veterans who suffer from traumatic events. Not doing so sends a message that devalues the sacrifices that they have made which then perpetuates the stigma associated with their discharge status, but also reinforces the negative outlook of mental health within military culture. Veterans should not have to suffer in silence for enduring what was demanded of them and then be casted aside because their organization feels that their value has expired.  

In 2016, over 1.5 million of the 5.5 million Veterans who entered the VA hospitals, had PTSD or other mental health diagnosis. That’s a staggering number especially when you consider the constant influx of Veterans who are returning home from deployment. Compared to the general population, suicide death rates are higher in Veterans, and furthermore female Veterans have a suicide rate of 35 per 100,000. Mental health services within the VA system have been on ongoing challenge as they try to meet the demand that Veterans need for crisis-intervention. As it is, mental health services are expensive for nonveterans, and even those who are insured may not have the adequate coverage to seek mental health services during a crisis episode. For Veterans returning home experiencing a mental health condition, this is disastrous as communities and VA systems both struggle to provide crisis stabilization and interventions. As a result, many Veterans experience depression on top of another mental health diagnosis like PTSD. Homelessness in Veterans is also increasing with more than 107,000 Veterans who are displaced. All of this is a perfect storm for a Veteran to feel like all hope is lost and consider suicide and reports reflect that with 21 Veterans, on average, dying of suicide every day. In society, there is a lot of talk about how all human beings are deserving of human equity. Human equity should include the ability to access mental health services (and healthcare as a whole), and the capability to navigate healthcare systems by having the support of organizations, communities, and effective public policy.

The military culture’s sphere of influence is completely different from civilian life. It is a complex system demanding everything military personnel can give, but it can often fall short when the time comes to giving back to Veterans. The sad truth is, Veterans often confront too many barriers when attempting to access appropriate timely care and treatment. It isn’t a secret that mental health disorders and other numerous challenges, such as substance use disorder, stem from military service-related experiences. Yet, systems in place for Veterans are inadequately structured to meet the numerous public health issues confronting Veterans and, subsequently, their families. Accessibility to healthcare services, including mental health, needs to encompass a wide net of effective policies and programs but also infused with the knowledge of how Veterans occupy the various systems that they live in and are affected by them. Too often in healthcare, clients are evaluated solely based off a diagnosis and without ever including who they are and their lived experiences. These are large, missed opportunities for clinicians to home in on invaluable information that can help formulate more effective treatment plans in conjunction with innovative and effective public policy. Hubs like VA systems are a great resource for Veterans, but we need to make sure the avenues of accessibility remain open for all Veterans that are eligible. It is very rare that a solution to a problem ever stands alone, and this perspective should continue to be a driver as community engagement and expansion in healthcare accessibility is needed. Veterans answered the call of duty without hesitation so now we must not drag our feet when Veterans need us the most in a war that poor public policy, lack of community programs and military culture has waged on them.

References:

• Belperio, A,. Korshak,L., & Moy, E. (2020). Hepatitis C Treatment in Minority Veterans. Office of Health Equity. Retrieved online at https://www.va.gov/HEALTHEQUITY/Hepatitis_C_Treatment_in_Minority_Veterans.asp

• Burek, Gregory, M.D. (2018). Military Culture: Working With Veterans. The American Journal of Psychiatry Residents’ Journal. Retrieved online at https://ajp.psychiatryonline.org/doi/pdf/10.1176/appi.ajp-rj.2018.130902

• Centers for Disease Control & Prevention (2018). CDC Estimates Nearly 2.4 Million Americans Living with Hepatitis C. U.S. Department of Health & Human Services. Retrieved online at https://www.cdc.gov/nchhstp/newsroom/2018/hepatitis-c-prevalence-estimates-press-release.html

• Duncan, M. S., Alcorn, C. W., Freiberg, M. S., So-Armah, K., Patterson, O. V., DuVall, S. L., ... & Brittain, E. L. (2021). Association between HIV and incident pulmonary hypertension in US Veterans: a retrospective cohort study. The Lancet Healthy Longevity.

• HepMag (2019). Veterans and Hepatitis C. Retrieved online at https://www.hepmag.com/basics/hepatitis-c-basics/veterans

• Hester, R. D. (2017). Lack of access to mental health services contributing to the high suicide rates among veterans. International journal of mental health systems, 11(1), 1-4.

• Maguire, Elizabeth (2021). Providing clean syringes to Veterans who inject drugs. VAntage Point (Blog). Retrieved online at https://blogs.va.gov/VAntage/89943/providing-veterans-inject-drugs-clean-syringes/

• Military Officers Association of America blog (2017). Veterans and Opioid Addiction. Retrieved online at https://www.moaa.org/content/publications-and-media/features-and-columns/health-features/veterans-and-opioid-addiction/#.YNxcrmTZy_0.twitter

• Pebody.,R. (2018). Life expectancy for people living with HIV. AIDSmap. Retrieved online at https://www.aidsmap.com/about-hiv/life-expectancy-people-living-hiv

• Schultz, Jennifer (2017, November 10). Veterans By the Numbers. The NCSL Blog. Retrieved online at https://www.ncsl.org/blog/2017/11/10/veterans-by-the-numbers.aspx#:~:text=There%20are%2018.8%20million%20veterans%20living%20in%20the,rise.%20Veterans%20tend%20to%20be%20older%20than%20nonveterans

• Sico, J. J., Kundu, S., So‐Armah, K., Gupta, S. K., Chang, C. C. H., Butt, A. A., ... & Stewart, J. C. (2021). Depression as a Risk Factor for Incident Ischemic Stroke Among HIV‐Positive Veterans in the Veterans Aging Cohort Study. Journal of the American Heart Association, 10(13), e017637.

• Sisk, R. (2021). ‘Dirty, Embarrassing Secret:’ Veterans with PTSD Struggle to Shed Stigma of Bad Paper Discharges. Military. Military.com. Retrieved online at https://www.military.com/daily-news/2021/04/21/dirty-embarrassing-secret-veterans-ptsd-struggle-shed-stigma-of-bad-paper-discharges.html

• Substance Abuse and Mental Health Services Administration. (2020). 2019 National Survey on Drug Use and Health: Veteran Adults. Retrieved online at https://www.samhsa.gov/data/sites/default/files/reports/rpt31103/2019NSDUH-Veteran/Veterans%202019%20NSDUH.pdf

• U.S Department of Veterans Affairs, (2020). Human Immunodeficiency Virus (HIV) - VA IS THE LARGEST SINGLE PROVIDER OF HIV CARE IN THE UNITED STATES. Fact sheet. Retrieved online at https://www.hiv.va.gov/pdf/HIV-program-factsheet.pdf

• Wisely, Rene (2018). Why Are Hep C Infections Skyrocketing? Opioid Abuse to Blame. Michigan Medicine. Retrieved online at https://healthblog.uofmhealth.org/hep-c-infection-and-drug-abuse

• Zuchowski, J. L., Hamilton, A. B., Pyne, J. M., Clark, J. A., Naik, A. D., Smith, D. L., & Kanwal, F. (2015). Qualitative analysis of patient-centered decision attributes associated with initiating hepatitis C treatment. BMC gastroenterology, 15(1), 1-10.

Post-PHE: Continuity in Care for Vulnerable Populations is Critical

On July 20th, the United States extended its existing declaration of Public Health Emergency (PHE) in response to the COVID-19 pandemic for 90 days. Previously, the PHE had been renewed 6 times under the previous and current administrations. The PHE declaration may be extended past October 20th, 2021, should the Secretary of Health and Human Services (HHS), Xavier Becerra, renew the declaration.

Pandemic response and relief funding from the federal government has come with strings attached in order to ensure those funds are directed toward those who need the help the most. Most of these strings operate as both “stick and carrot” and one of the more interesting “carrots” was the increase of federal dollars supporting state Medicaid programs for the trade-off of maintaining those Medicaid rolls, temporarily ceasing redetermination and reenrollment activities, allowing people to remain on Medicaid rolls through the PHE without having to go through the usual hoops of proving their eligibility on a more regular basis.

While the previous administration directed states to anticipate a return to usual work after the PHE, engaging in a massive redetermination effort inside of 6 months of the PHE ending, earlier this month, the Biden administration informed states that redetermination period would be extended to 12 months in order to avoid an artificial “bulge” of redeterminations and eligibility checks and, ultimately, a potential annual cycle of concentrated renewals in a short window of time. It’s important to remember, as we discuss Medicaid redetermination, rules vary by state and those disenrolled during redetermination are not necessarily ineligible, they may merely not have had an opportunity to respond to a request for information for a variety of reasons.

The guidance from the Biden Administration speaks directly to this issue, stating states should consider providing a “reasonable” amount of time for clients to provide additional information for redetermination. The administration’s idea of a reasonable amount of time is 30 days. Louisiana, as an example, typically only allows for 10 days from the date in which a paper letter has been mailed to a Medicaid recipient for that same recipient to respond. If the recipient is ill, needs to gather supporting evidence from multiple sources, the mail is slow, or any number of factors outside of their control, they may be unceremoniously disenrolled. A mass redetermination effort in a shortened period of time runs a significant risk of disenrolling otherwise eligible clients but for a process that leaves less than no room for delay or mistake. Indeed, a 2019 report from Louisiana’s Health department found that 85% of eligibility cases were closed for a lack of response to a request for information. Louisiana isn’t alone in these burdensome processes, which on the surface, appear to be aimed at discouraging residents from accessing Medicaid by way of process burden.

Overall, Medicaid and the Children’s Health Insurance Program (CHIP) saw an increase in enrollment starting in March 2020 and continuing today, though with a slower pace, after at least 2 years of decreasing enrollment, according to a Kaiser Family Foundation report. The same report shows Medicaid program enrollment has increased by about 20% - to about 81 million people – since February 2020 and expects many remain on Medicaid and CHIP rolls as a result of economic uncertainty and instability. 

At the intersection of Medicaid, COVID, and economic uncertainty are vulnerable communities, experiencing some of the highest rates of viral hepatitis and HIV. A tertiary benefit of Medicaid’s maintenance of coverage through the public health emergency is those living with viral hepatitis and HIV have been able to more readily seek coverage and care. The problem is a complete lack of “warm hand-off” between Medicaid programs and other assistance programs clients could be significantly advantaged by. Particularly, because of the overlap in intersections of oppression and risk (which some more readily recognize as “social determinants of health”), AIDS Drug Assistance Programs, Ryan White services, and other support services (both publicly and privately funded) are critical tools in our public health safety net.

Tossed off the front burner of public health efforts, “Ending the HIV Epidemic” activities have still been chugging along throughout the COVID-19 crisis. The only other concurrent running pandemic didn’t suddenly go away because COVID-19 came rushing to the forefront of our public health efforts. One of the things these other support programs struggle the most with is ensuring the public (and even health department and hospital case managers) know these programs exist. State Medicaid programs, AIDS service organizations, Ryan White Clinics, and all other safety net programs should be coordinating for the shift in patient load across appropriate programs now. These planning activities should not wait until the midnight hour. For county run COVID-19 testing sites and vaccination sites should be providing information to every, single person seeking a vaccine about available programming to meet the needs of community members. From rental assistance to food pantries to ADAPs, programs already reaching communities and families are the most ideal for starting the process of maintain care after the PHE ends. That starts with passive efforts like brochures and should continue with more active efforts, like engaging a state’s 311 information system with linkage to care tools, and more active still by employing navigators at the Medicaid level to assist clients in finding services, should those clients find themselves ineligible post-PHE.

While we’re not there yet (and it make take significantly longer than any of us like due to a lack of equitable global vaccine access and variant development), advocates, states, service providers, and patients should be planning for what comes next when the PHE eventually comes to an end. We cannot afford to lose people to care at this critical juncture.

Degrees of Separation: Social & Spatial Networks of HIV & HCV

In 1929, Frigyes Karinthy posited a theory many of us might attribute to Kevin Bacon: everyone on the planet is but six degrees of separation (or less) from one another. Depending on how one would measure a connection, that metric is likely far less than it was in 1929. Beyond social media marketing, connecting these networks of friends and friend-of-friends has been pretty important to the concepts of “partner testing and notification” utilized by disease intervention specialists to disrupt chains of transmission in terms of STIs and HIV. What’s been less well understood is the geographic relationship between areas experiencing outbreaks or “clusters” or the specific venues in which transmission occurs – social-spatial networks.

A study performed in New Delhi sought to better understand the relationship between social circle and gathering venue among “hard to reach populations” homeless people and/or, particularly, people who inject drugs. Originating recruitment from within community, asking community to propel recruitment, and paying particular attention to the “mutuals” between otherwise unconnected participants, the researchers sought to better understand the relationship of “risk” of transmission not just in behavior or large geographic area but in specific places in which specific behaviors are part of the culture – the community standards, if you will - of that venue. Researchers found 65% of participants had HCV antibodies, of which 80% had an “active infection” and most were unaware of their HCV status. Similarly, of those participants living with HIV, 65% were directly connected with another participant living with HIV. Researchers did not specify these connections to be causative – those connected did not necessarily transmit either virus to one another. Further, researchers found partaking at the most popular venue was associated with a 50% greater likelihood of a participant having an HIV or HCV diagnosis. Even if a participant did not access the most popular venue, if they associated with someone who did, their likelihood for being diagnosed with HIV or HCV was 14% higher. And the more degrees of separation a participant had from someone who accessed the most popular venue, the less the likelihood of a diagnosis.

The researchers conducting the study were hoping to identify methods of understanding that would allow for effective interventions that reach beyond the individual level. Can group behavior be influenced beyond recruitment and toward changes? Can harm reduction strategies or housing programs find greater efficacy, a better stretch of our dollars, by better understanding where these networks exist and how they operate?

Or is this association merely a by-product of sharing certain characteristics society has deemed unworthy of care? Those social ills that drive disparities in health and poverty and addiction may also drive those experiencing these harms of bias and negligence to seek a social network that at least understand their struggles. To be a little less alone in these struggles.

As is the nature of most things, a better understanding of behavior doesn’t always lend itself to building positive interventions. The same ability to navigate networks in areas where people living with HIV are discriminated against and people who inject drugs can easily be criminalized, rather than connecting to care. With molecular surveillance generating the ire of HIV advocates over fear of this kind of detailed knowledge being used by law enforcement, advocates should also keep a keen eye on how networks may be weaponized as well.

Understanding the spatial relationship within a social network could be a powerful public health tool that shifts our focus from individual intervention to far more meaningful interventions, so long as we can keep the focus of this type of research and the information gathered from it squarely aimed at building up the “public” part of public health rather the continuing to push the responsibility of public health on individual behavior.

Potentially Powerful Tools: A Vaccine in the Fight Against HCV

In 1989, Sir Michael Houghton helped discover the Hepatitis C Virus. Last year, he was awarded the Nobel Prize in Medicine for this same discovery. Now, he’s aiming to create a vaccine against the virus.

Just a few weeks ago, Houghton announced an effort at the University of Alberta’s Li Ka Shing Applied Virology Institute that could have a adjuvanted recombinant vaccine ready for global deployment by 2029. Both new mRNA and viral vector vaccines, used in the COVID-19 vaccines currently authorized by the Food and Drug Administration under an emergency use authorization, have the potential strength to produce multiple kinds of antibodies, solving a long-held problem in the search for an HCV vaccine.

A couple of words of caution: A recent study, using two viral vectors, while successful producing HCV specific T-cells, failed to prevent chronic HCV infection. The last decade has seen several attempts at developing an HCV vaccine but few have made it to human trial, specifically because of evasive properties of the virus’ genotypes to behave differently or escape the body’s natural defenses.

If Houghton and his team are successful, a 2029 launch would likely still have much of the globe well behind the World Health Organization’s 2030 goals but adding a clear, definitive prevention tool stopping chains of transmission would, in theory, help countries playing “catch-up”. With complications from Hepatitis C killing more than 400,000 people annually – and possibly more in the coming years due to COVID-19-related disruptions in care – a vaccination effort could very easily save millions of lives and save billions in public health and health care funding. Houghton suggested Canada alone could see a reduction in HCV-related costs of 98%, or $20 million as opposed to $1 billion – annually due to the high costs of direct acting agents, which are the current gold standard in HCV care and can be curative.

However, if global access to COVID-19 vaccine difficulty and notable vaccine distrust and failure to uptake have taught us anything, having the technology is not the same as having the technology. COVID-19 doesn’t appear to be slowing down, despite recurrent waves, and supply demand on shared vaccine ingredients could find HCV deprioritized.

Additionally, there’s other potential complications to consider. While the United States has seen an increase in Hepatitis B vaccine acceptance, in part thanks to an infant vaccination schedule inclusive of HBV, a study published last year found waning immunity over the years post-vaccination. Now, the CDC’s information page does not recommend HBV boosters and technology may differences may naturally boost efficacy of vaccines but anything that needs additional follow up, like multi-stage vaccines or boosters, are always prone to follow-up failures. And – yet again – COVID-19 provides an excellent case study in this (and all other hidden asterisks). With “anti-vax” sentiments rising at exceptional rates, especially associated with “new” technologies, adding yet another vaccine to the schedule may find barriers in acceptance other common vaccines haven’t run into, at least not on this scale.

Nevertheless, a successful HCV vaccine that answers the challenges of the virus, the conspiracy, and the supply would be a game-changer (to use an unfortunately over-used phrase).

If advocates and policy makers have learned anything, being well prepared for an ever-changing environment in terms of technological advancements, the advancement of anti-science sentiments, and a whole host of other challenges is to our benefit. Analyzing the years between now and, hopefully, 2029, perfecting routine vaccination programs and ensuring actual global equity in access and distribution are critical to making sure this kind of discovery doesn’t go to waste.

Community Roundtable Emphasizes Impacts of Covid-19

In late June, Community Access National Network hosted a virtual Community Roundtable on Covid-19’s Impacts on HIV, Viral Hepatitis, Sexually Transmitted Infections, and Substance Use Disorder. CANN’s policy consultant (yours truly) was joined by A. Toni Young, founder and executive director at Community Education Group, and Kenneth Westberry, senior manager of policy and government relations at the National Coalition of STD Directors, in discussing the wide-reaching impacts of the Covid-19 pandemic and subsequent public health emergency on the nation’s longest and most well-funded public health service providers…so far. Attendees included representatives from patient advocacy organizations, state and local health departments, clinical laboratories, hospitals, pharmseutical companies, and federally or state funded service providers from 20 states and the District of Columbia. The event was sponsored by ADAP Advocacy Association, ViiV Healthcare, Abbvie, Merck, and Janssen Pharmaceutical Companies of Johnson & Johnson.

Toni started off a whirl wind of information with making direct comparisons between the previous year’s overdose death rates and this year’s and emphasizing the plight of West Virginia by comparing the nation’s increases to the state’s. This opened the roundtable with a clear message that would ring through with every new data point: the pandemic’s impacts are not equal. Building upon the point made in a blog post earlier this year, Toni pointed to a stark decrease in HCV screening and, more pointedly, reviewed available data on HCV medication access – showing a decrease of 37-48% during the first few months of the public health emergency. She warned listeners not view initial lower incidence rates as optimistic, rather these findings should be viewed under a lens of a lack of access to screening and services. She further stressed the lack of SUD services accessed at the beginning of the pandemic resulting in alarming increases in injection drug use-related HIV diagnoses as a year over year trend with 2021 looking even more worrisome. Rounding out this segment of the roundtable, Toni cautioned attendees: we have good reason to believe screenings will not necessarily return to their pre-pandemic levels in a speedy fashion or without additional effort and funding.

I followed Toni’s dynamic presentation, picking up with the Centers for Disease Control and Prevention surveillance reports for 2015-2019 – reminding the audience federal level data often lags by two years and the CDC has already presented data for 2020 on fewer HIV tests being performed. This portion of the presentation highlighted disparities in HIV along geography, racial and ethnic lines, as well as sex assigned at birth. I needed to note: gender identity is not uniformly collected data in HIV surveillance. The CDC’s pre-exposure prophylaxis data was similarly…unfortunate. With right around 10% for Hispanic/Latino people identified as living at risk for HIV receiving PrEP services and medication in 2018 and just over 6% of African American/Black people living at risk for HIV receiving PrEP services and medication in the same year. Similarly, people assigned male at birth were more likely than people assigned female at birth to have access to PrEP. Looking to the pandemic, I cited two Kaiser Family Foundation reports one on the similar disparate impacts between HIV and Covid-19 among racial and ethnic communities compared to their white peers and the other on Covid-19’s impact on Ryan White service providers. The KFF reports showed service providers reporting an increase in patients without insurance or receiving Medicaid, some clinics reporting a decrease in patient retention and other reporting increases in patient retention, and clinics reporting a decrease in patient demand for HIV screenings and accessing PrEP services.

The final presenter, Kenneth Westberry, began by giving a brief overview of the state of STI’s as public programming: a steady increase year over year in reported STI incidence, a lack of significant funding increases in the last 15 years, and nearly 40% of clinics reporting a decrease in hours or closing entirely during the height of Covid-related restrictions. Of the particular burdens, Covid-19 brought state and local health departments, nearly 80% redeployed their staff from STI programming to Covid-19 programming, reducing capacity to manage STI caseloads, and facing an unprecedented lack of testing supplies as manufacturers also refocused on making Covid-19 tests. Kenneth then reviewed the findings of NCSD’s surveys seeking to evaluate the state of STI programs (phase I, phase II, and phase III) showing many health departments are still behind in terms of having enough staff to meet the needs of both Covid-19 as a public health emergency and regular STI programs.

Moving onto the nuts and bolts of the federal response to Covid-19, Kenneth highlighted the role of disease intervention specialists historically and in response to Covid-19, answering the “why” the Biden Administration’s change in stature toward the pandemic was critically necessary. Particularly, the American rescue Plan Act added $1.13 billion to expand and sustain current DIS and the President’s budget request includes an increase in funding for STI programs in addition to current spending levels.

The three panelists then spent a brief amount of time discussing the funding weaknesses exposed by Covid-19 diverting resources. In a particular “shot across the bow”, Toni stated “Health departments and appropriators have learned Ryan White dollars aren’t sacrosanct anymore. If the emergency is big enough, they can grab those monies,” urging advocates to keep on their toes and watch actions at the state and local as much as they do at the federal level. Each panelist also mentioned a need for greater collaboration between “silos” in order to reach the nation’s lofty public health goals with regard to HIV, HCV, STI’s, and SUD.

Panelists wrapped up by highlighting upcoming events for each organization, sharing resources, and once again thanking each other, attendees, and sponsors. The slide deck can be downloaded here.

Future events will be hosted to ensure we’re “tracking what’s on the ground” and connecting community partners with pertinent resources and information.

Rising Morbidity: Viral Hepatitis Co-Infection with HIV and Age All Associated with Increased Rates of Liver Cancer

In February, researchers associated with numerous universities across Canada and the United States published one of the most comprehensive data reviews thus far conducted on the incidence rates of the most common type of liver cancer among people living with HIV/AIDS (PLWHA) and PLWHA co-infected with viral hepatitis. The study reviewed data collected as part of the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD), conducted between 1996 and 2015, with clinical data from 109,283 participants. Conclusions from the study were fairly straight-forward: the combination of HIV status (mono-infection), co-infection with viral hepatitis (HBV and/or HCV) and age all correlated with an increased chance of developing liver cancer (hepatocellular carcinoma [HCC]). The hope of researchers, as evidenced in the study’s introduction was to “inform expectations for other regions with a substantial burden of HIV and HBV-HCV coinfection but with delayed cART [combination antiretroviral therapy] scale-up and limited access to viral hepatitis treatment”.

While most research papers wait to include study limitations at the end, I prefer to open with them as prefacing allows for contextualizing data. The first and primary limitation on the review is clinical information reviewed was necessarily from those people linked to care and correlations provided by the data in the study cannot be applied to the diagnosed-but-not-in-care or undiagnosed population. Second, researchers note, information on relevant, individual health factors were missing from significant portions of participants data (example: smoking and drinking habits, natural clearance of HCV, fibrosis score, and HIV exposure risk). Additionally, data collection was not uniform across all participating entities at the time of linkage to care, though a quality analysis was used to help even things out and ensure the integrity of data comparisons. This lack of uniform protocol also included certain sites not administering or participants not receiving HCV or HBV screening. The last, though likely most significant limitation of the study is the data were collected prior to the advent of curative direct acting agents (DAAs) for HCV, and conclusions cannot be made on the potential positive impacts of readily available DAAs.

A limitation not mentioned and data unassessed is any reference between older ART regimens and newer ones, in which toxicity and tolerability is commonly known to be considerably improved with newer regimens. Liver health monitoring is fairly standard, among other relevant patient labs, for PLWHA because of a relationship between ART and liver health. While it’s understandable researchers who generally enjoy significant funding from manufacturers may wish to avoid broaching this topic, not mentioning the issue, even to say “we can’t make any conclusions on cART tolerability and toxicity as an indicator for adherence or risk of developing HCC” misses an incredibly important elephant in the room for researchers, providers, and patients alike.

Instead, researchers chose to focus on cART “eras” (1996-2000 [A], 2001-2005[B], and 2006-2015[C]), in which there’s a positive correlation between age and era; or those aging with HIV were more likely to be diagnosed with HCC. Highest rates of HCC diagnosis by cART area are as follows: A – between 50 and 60 years-old (HBV co-infection with HIV), B – lower end 70-80 (HCV co-infection with HIV), and C – upper end 70-80 (HCV and HBV co-infection with HIV). This data is particularly valuable on its own, however, as the associated risk cohort shift appears to be very closely related to age (ie. those in the upper end of the C “era” are also those to first receive effective cART and the 20-year age gap between the C and A cART eras).

Ultimately, PLWHA were more than 3 times as likely as the general population to develop HCC and more than 20 times more likely to develop HCC if co-infected with viral hepatitis. HCC incidence among study participants fell along rather predictable lines in terms of HIV related clinical monitoring metrics; those with higher viral loads and lower CD4 counts were more likely to develop HCC.

The study’s finding highlight the need for ensuring access to DAAs and HBV vaccines, ready ART uptake upon linkage to care, and strengthening the integrity of AIDS Drug Assistance Programs, Medicaid Programs, and care provided to incarcerated persons – specifically, ensuring the inclusion of coverage of DAAs in these.

Advocates, providers, and patients can review DAA coverage inclusion in ADAPs and Medicaid and harm reduction policies impacting HIV and HCV with Community Access National Network’s quarterly HIV-HCV Co-Infection Watch report.